[Federal Register Volume 71, Number 26 (Wednesday, February 8, 2006)]
[Notices]
[Pages 6499-6500]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-1694]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-06-0576]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
the CDC Reports Clearance Officer at (404) 639-4766 or send an e-mail 
to [email protected]. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC or by fax to (202) 395-6974. 
Written comments should be received within 30 days of this notice.

Proposed Project

    Possession, Use, and Transfer of Select Agents and Toxins (OMB 
Control No. 0920-0576)--Revision--Office of the Director (OD), Centers 
for Disease Control and Prevention (CDC).

Background and Brief Description

    The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (Pub. L. 107-188) specifies that the Secretary of 
Health and Human Services (HHS) shall provide for the establishment and 
enforcement of standards and procedures governing the possession, use, 
and transfer of select agents and toxins that have the potential to 
pose a severe threat to public health and safety. The Act specifies 
that entities that possess, use, and transfer these select agents 
register with the HHS Secretary. The HHS Secretary has designated CDC 
as the agency responsible for collecting this information.
    CDC is requesting continued OMB approval to collect this 
information through the use of five separate forms. These forms are: 
(1) Application for Registration, (2) Request to Transfer Select Agent 
or Toxin, (3) Report of Theft, Loss, or Release of Select Agent and 
Toxin, (4) Report of Identification of Select Agent or Toxin, and (5) 
Request for Exemption.
    The Application for Registration (42 CFR 73.7(d)) is used by 
entities to register with CDC. The Application for Registration 
requests facility information; a list of select agents or toxins in 
use, possession, or for transfer by the entity; characterization of the 
select agent or toxin; and laboratory information. Estimated average 
time to complete this form is 3 hours, 45 minutes for an entity with 
one principal investigator working with one select agent or toxin. CDC 
estimates that entities will need an additional 45 minutes for each 
additional investigator or agent. In our regulatory analysis, we have 
estimated that 70% of the 350 entities have 1-3 principal 
investigators, 15% have 5 principal investigators, and 15% have 10 
principal investigators. We have used these figures to calculate the 
burden for this section. Estimated burden for the Application for 
Registration is 2,191 hours.
    Entities may amend their registration (42 CFR 73.7(h)(1)) if any 
changes occur in the information submitted to CDC. To apply for an 
amendment to a certificate of registration, an entity must obtain the 
relevant portion of the application package and submit the information 
requested in the package to CDC. Estimated time to amend a registration 
package is 1 hour.
    The Request to Transfer Select Agent or Toxin form (42 CFR 73.16) 
is used by entities requesting transfer of a select agent or toxin to 
their facility and by the entity transferring the agent. CDC revised 
the Request to Transfer Select Agent or Toxin form by removing the 
requirement that entities provide written notice within five business 
days when select agents or toxins are consumed or destroyed after a 
transfer. Estimated average time to complete this form is 1 hour, 30 
minutes.
    The Report of Theft, Loss, or Release of Select Agent and Toxin 
form (42 CFR 73.19(a)(b)) must be completed by entities whenever there 
is theft, loss, or release of a select agent or toxin. Estimated 
average time to complete this form is 1 hour.
    The Report of Identification of Select Agent or Toxin form 42 CFR 
73.5(a)(b) and 73.6(a)(b)) is used by clinical and diagnostic 
laboratories to notify CDC that select agents or toxins identified as 
the result of diagnostic or proficiency testing have been disposed of 
in a proper manner. In addition, the form is used by Federal law 
enforcement agencies to report the seizure and final disposition of 
select agents and toxins. Estimated average time to complete this form 
is 1 hour.
    The Request for Exemption form (42 CFR 73.5(d)(e) and 73.6(d)(e)) 
is used by entities that are using an investigational product that are, 
bear, or contain select agents or toxins, or in cases of public health 
emergency. Estimated average time to complete this form is 1 hour.
    In addition to the standardized forms, this regulation also 
outlines situations in which an entity must notify or may make a 
request of the HHS Secretary in writing. An entity may apply to the HHS 
Secretary for an expedited review of an individual by the Attorney 
General (42 CFR 73.10(e)). To apply for this expedited review, an 
entity must submit a request in writing to the HHS Secretary 
establishing the need for such action. The estimated time to gather the 
information and submit this request is 30 minutes. CDC has not 
developed standardized forms to use in the above situations. Rather, 
the entity should provide the information as requested in the 
appropriate section of the regulation.
    An entity may also apply to the HHS Secretary for an exclusion of 
an attenuated strain of a select agent or toxin that does not pose a 
severe threat to public health and safety (42 CFR 73.3(e)(1) and 
73.4(e)(1)). The estimated time to gather the information and submit 
this request is 1 hour.
    As part of the requirements of the Responsible Official, the 
Responsible Official is required to conduct regular inspections (at 
least annually) of the laboratory where select agents or toxins are 
stored. Results of these self-inspections must be documented (42 CFR 
73.9(a)(5)). CDC estimates, that, on average, such documentation will 
take 1 hour.
    As part of the training requirements of this regulation, the entity 
is required to record the identity of the individual trained, the date 
of training, and the means used to verify that the employee understood 
the training (42 CFR 73.15(c)). Estimated time for this documentation 
is 2 hours per principal investigator.
    An individual or entity may request administrative review of a 
decision denying or revoking certification of registration or an 
individual may appeal a denial of access approval (42 CFR 73.20). This 
request must be made in writing and within 30 calendar days after the 
adverse decision. This request should include a statement of the 
factual basis for the review. CDC estimates the time to prepare and 
submit such a request is 4 hours.
    Finally, an entity must implement a system to ensure that certain 
records and databases are accurate and that the authenticity of records 
may be verified (42 CFR 73.17(b)). The time to

[[Page 6500]]

implement such a system is estimated to average 4 hours.
    The cost to respondents is their time to complete the forms and 
comply with the reporting and recordkeeping components of the Act plus 
a one-time purchase of a file cabinet (estimated cost $400) to maintain 
records. The total estimated annualized burden hours are 7,785.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
             CFR reference                   Data collection          Number of     Responses per    burden per
                                                instrument           respondents     respondent       response
----------------------------------------------------------------------------------------------------------------
73.7(d)...............................  Registration Application              350               1           3.75
                                         Form.
73.7(d)...............................  Additional Investigators.             245               2       45/60
73.7(d)...............................  Additional Investigators.              53               4       45/60
73.7(d)...............................  Additional Investigators.              52               9       45/60
73.7(h)(1)............................  Amendment to Registration             350               2           1
                                         Application.
73.19(a)(b)...........................  Report of Theft, Loss, or              12               1           1
                                         Release.
73.5 & 73.6(d-e)/73.3 & 73.4(e)(1)....  Request for Exemption                  17               1           1
                                         Form/Exclusion.
73.16.................................  Request to Transfer......             350               2           1.5
73.5 & 73.6(a)(b).....................  Report of Identification.             325               4           1
73.10(e)..............................  Request expedited review.              10               1       30/60
73.9(a)(5)............................  Documentation of self-                350               1           1
                                         inspection.
73.15(c)..............................  Documentation of training             350               1           2
73.20.................................  Administrative Review....               5               1           4
73.17.................................  Ensure secure                         350               1           4
                                         recordkeeping system.
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    Dated: February 1, 2006.
Betsey Dunaway,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. E6-1694 Filed 2-7-06; 8:45 am]
BILLING CODE 4163-18-P